Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus (IONTO)
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|ClinicalTrials.gov Identifier: NCT00941993|
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media Chronic Otitis Media Recurrent Acute Otitis Media||Device: Iontophoresis System (Acclarent)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First in Man Evaluation of the Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to the External Auditory Apparatus (FIM Iontophoresis Study)|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Experimental: local anesthesia
tympanic membrane local anesthesia delivery system
Device: Iontophoresis System (Acclarent)
Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine.
Other Name: Acclarent
- Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment [ Time Frame: Day 0 ]Investigator performed a gentle tap of the tympanic membrane to assess whether adequate anesthesia was achieved following local anesthesia by iontophoresis. All subjects for which an ear procedure was attempted were considered to have achieved anesthesia effectiveness.
- Evaluate Any Adverse Effects Associated With the Iontophoresis System (Adverse Device Effects). [ Time Frame: Day 0 ]
- Patient Tolerability of Iontophoresis Procedure Will be Measured Using a Wong Baker Faces Pain Scale [ Time Frame: Day 0 ]
Includes all subjects for whom Iontophoresis current delivery was initiated.
The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.
The Wong-Baker scores are reported by subject.
- Subject/Parent Reported Satisfaction With the In-office Procedure [ Time Frame: Day 0 ]
Adult subjects or parents of pediatric subjects were asked to rate their agreement or disagreement with the statement: 'Overall, I am satisfied with the whole procedure'. Response options included: 'Strongly Disagree', 'Disagree', 'Neutral', 'Agree' or 'Strongly Agree'. The number of respondents who reported that they 'agree' or 'strongly agree' that they were satisfied with the whole procedure are reported.
The analysis population does not include the full study cohort as this survey question was implemented during, not prior to, the enrollment period.
- Patient Tolerability of In-office Ear Treatment Using the Wong Baker FACES Pain Scale. [ Time Frame: Day 0 ]
The Wong-Baker FACES pain scoring system is a subject-reported instrument using a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'.
Pain scores were recorded for all subjects for which an ear procedure was attempted.Pain scores are presented by subject, as an average of pain scores for both ears.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941993
|United States, South Carolina|
|Spartanburg, South Carolina, United States, 29303|
|Principal Investigator:||Henry "Fritz" Butehorn, III, MD||Spartanburg ENT|